Ex Parte Derwin et al

Patent Trial and Appeal Board

Sep 25, 2017

14097328 (P.T.A.B. Sep. 25, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O.Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
14/097,328 12/05/2013 Kathleen Derwin CCF-018284 US DIV 5 3277
26294 7590 09/27/2017
TAROLLI, SUNDHEIM, COVELL & TUMMINO L.L.P.
1300 EAST NINTH STREET, SUITE 1700
CLEVELAND, OH 44114
EXAMINER
TEMPLETON, CHRISTOPHER L
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
09/27/2017 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
rkline @ tarolli. com
docketing@tarolli.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KATHLEEN DERWIN, AMIT AURORA,
JOSEPH P. IANNOTTI, and JESSE A. McCARRON1
Appeal 2016-006258
Application 14/097,3282
Technology Center 3700
Before DONALD E. ADAMS, JOHN E. SCHNEIDER, and
RYAN H. FLAX, Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims directed to a biocompatible tissue graft. Claims 33—45 and 47—52 are
on appeal as rejected under 35 U.S.C. § 103(a). We have jurisdiction under
35 U.S.C. § 6(b).
We affirm.
1 Appellants identify the Real Party in Interest as “The Cleveland Clinic
Foundation.” App. Br. 3.
2 Appellants identify that U.S. Patent Application No. 12/934,791 (Appeal
2016-001791) is related to the application on appeal. App. Br. 4. We note,
U.S. Patent Application No. 13/663,936 (Appeal 2016-005057) is also
related to the application on appeal.
Appeal 2016-006258
Application 14/097,328
STATEMENT OF THE CASE
The Specification states the “invention relates to a reinforced,
biocompatible tissue graft.” Spec. 14. The Specification further states
“[t]he tissue graft in accordance with the present invention includes an
extracellular matrix (ECM) patch (or ECM) and a reinforcing means. The
ECM can be derived from any mammalian ECM, such as fascia, and in
particular, fascia lata from humans.” Id. 132. The Specification further
states:
The reinforcing means can include any structure or
material that is applied to the ECM, is capable of mitigating
tearing of the graft when the graft is fixed to tissue being treated,
and/or is capable of increasing or improving the fixation
retention properties of the tissue graft beyond that which is
present in a patch of the ECM alone.
Id. 134. “In one aspect of the invention, the reinforcing means can include a
thread or strands of fiber(s).” Id. 135. The Specification further states, “[i]n
an aspect of the invention, the fibers and/or the ECM can be mechanically,
chemically or biologically modified to enhance adhesion between the fibers
and ECM to further secure the fibers to the ECM. This modification may
occur before or after the fibers are incorporated into the ECM.” Id. 139.
Claims 33, 38, and 45 are the independent claims and are reproduced
below:
33. A biocompatible tissue graft comprising:
an extracellular matrix patch; and
at least one fiber stitched into the patch in a cross-hatched
reinforcement pattern, the at least one stitched fiber mitigating
tearing and/or improving fixation retention of the patch.
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38. A biocompatible tissue graft comprising:
a fascia patch; and
at least one fiber stitched into the patch in a cross-hatched
reinforcement pattern to mitigate tearing and/or improve fixation
retention of the patch, the at least one fiber being formed from at
least one of PLA and PGA.
45. A biocompatible tissue graft comprising:
a fascia patch; and
at least one fiber stitched into the patch in a cross-hatched
reinforcement pattern, the at least one stitched fiber mitigating
tearing, improving fixation retention, resisting cyclic fatigue
loading at physiologically relevant loads, and increasing the
suture retention strength of the patch at least two times, and
maintaining these properties during simulated in vivo conditions;
wherein the fascia patch has a strip shape that is suitable
for bridging muscle or tendon defects, the at least one fiber
stitched into the patch increasing suture retention strength of the
patch to greater than 100N;
wherein the at least one fiber constitutes a polymer braid
having a PGA core and a sheath around the core comprising PLA
and PGA.
App. Br. 41, 42, 43 (Claims App’x).
The following rejections are on appeal:
Claims 33—37, 43, 48, 49, and 52 stand rejected under 35 U.S.C.
§ 103(a) over Badylak3 and Datta.4 Final Action 2.
3 US 2004/0006395 A1 (Jan. 8, 2004) (“Badylak”).
4 US 2007/0190108 A1 (Aug. 16, 2007) (“Datta”).
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Claims 38-42, 44, 45, 47, 50, and 51 stand rejected under 35 U.S.C.
§ 103(a) over Bilbo5 and Datta. Id. at 4.
FINDINGS OF FACT
We adopt the Examiner’s findings of fact, reasoning on scope and
content of the claims and prior art, and conclusions set out in the Final
Action and Answer. The findings of fact set forth below are provided to
highlight certain evidence.
FF1. Appellants and their declarant (Dr. Badylak) equate
ECM, fascia, and collagen (as well as submucosa) as synonymous
terms. App. Br. 24 (“ECM, which is a discontinuous collagen
network”), 31 (Table 1 indicates ECM is collagen, “ECM, which is a
discontinuous collagen network”), 32 (“collagen (ECM)”), 34
(“collagen-rich ECM”), 36—37 (“fascia, which is one type of ECM
(see Paragraph [0033] of Appellants’ published U.S. patent
application). . . discussion of the ECM patch of Badylak in the
Declaration is equally applicable to the fascia patch of Bilbo.”);
Badylak Deck68—9 (discussing Badylak’s disclosure of
ECM/submucosa patch), || 15, 17 (“ECM [extracellular matrix] ... is
a discontinuous collagen network”), 123 (“collagenous sources, such
as fascia”).
FF2. The Specification describes the invention as open to
combining ECM (e.g., collagen, fascia, submucosa) material with
5 US 2002/0103542 A1 (Aug. 1, 2002) (“Bilbo”).
6 Stephen F. Badylak Declaration Under 37 C.F.R. § 1.132 (Jan. 23, 2015)
(“Badylak Deck”).
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other materials in forming a patch, describing, “[t]he tissue graft in
accordance with the present invention includes an extracellular matrix
(ECM) patch (or ECM) and a reinforcing means,” and
[t]he reinforcing means can include any structure or
material that is applied to the ECM, is capable of mitigating
tearing of the graft when the graft is fixed to tissue being treated,
and/or is capable of increasing or improving the fixation
retention properties of the tissue graft beyond that which is
present in a patch of the ECM alone.
Spec. 32, 34. The Specification further describes, “[i]n an aspect of
the invention, the fibers and/or the ECM can be mechanically,
chemically or biologically modified to enhance adhesion between the
fibers and ECM to further secure the fibers to the ECM. This
modification may occur before or after the fibers are incorporated into
the ECM.” Id. 139.
FF3. Datta discloses “reticulated elastomeric matrices ... for
implantable devices into or for topical treatment of patients, such as
humans and other animals, for surgical devices, tissue augmentation,
[and] tissue repair,” for example, for an “orthopedic application []
relating] to a repair, reconstruction, regeneration, augmentation, gap
interposition, or any mixture thereof of a tendon,” such as “rotator
cuff repair.” Datta, abstract, H 2, 41, 315; see also Final Action 2—
16, and Ans. 2—18 (discussing Datta).
FF4. Datta discloses its “elastomeric material of which
elastomeric matrix 10 is constituted may be a mixture or blend of
multiple materials,” for example polycarbonate and collagen, such
that “the reticulated elastomeric matrix of the invention facilitates
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tissue ingrowth by providing a surface for cellular attachment,
migration, proliferation and/or coating (e.g., collagen) deposition,”
and may include “connective tissue” and “biopolymer, such as
collagen, [or] elastin” and “extracellular matrix components.” Datta
65, 73, 80, 232, 267, 268, 317; see also Final Action 2—16, and
Ans. 2—18 (discussing Datta).
FF5. Datta discloses:
An[] embodiment of the invention employs a collagen-
coated composite elastomeric implantable device, as described
above, configured as a sleeve extending around the implantable
device. The collagen matrix sleeve can be implanted at a tissue
repair and regeneration site, either adjacent to and in contact with
that site. So located, the collagen matrix sleeve can be useful to
help retain the elastomeric matrix 10, facilitate the formation of
a tissue seal and help prevent leakage. The presence of the
collagen in elastomeric matrix 10 can enhance cellular
ingrowth and proliferation and improve mechanical stability,
in one embodiment, by enhancing the attachment of fibroblasts
to the collagen. The presence of collagen can stimulate earlier
and/or more complete infiltration of the interconnected pores
of elastomeric matrix 10.
Datta 1253 (emphasis added); see also Final Action 2—16, and Ans.
2—18 (discussing Datta).
FF6. Datta discloses, “[t]he cells of elastomeric matrix 10 are
formed from clusters or groups of pores 20, which would form the
walls of a cell except that the cell walls 22 of most of the pores 20 are
absent or substantially absent owing to reticulation,” and “[i]n certain
embodiments, void phase 14 is continuous or substantially continuous
throughout elastomeric matrix 10, meaning that there are few if any
closed cell pores,” where “[i]n one embodiment, the volume of void
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phase 14, as just defined, is from about 10% to about 99% of the
volume of elastomeric matrix 10.” Datta Tflf 84, 88, 101; see also
Final Action 2—16, and Ans. 2—18 (discussing Datta).
FF7. Further to the preceding finding of fact, Datta discloses,
“some or all of the pores 20 of elastomeric matrix 10 are coated or
filled with a cellular ingrowth promoter,” where cellular ingrowth
“[promoters include naturally occurring materials that can be
enzymatically degraded in the human body or are hydrolytically
unstable in the human body, such as fibrin, fibrinogen, collagen,
elastin, hyaluronic acid and absorbable biocompatible
polysaccharides.” Datta 1237; see also Final Action 2—16, and Ans.
2—18 (discussing Datta). Thus, Datta teaches that its reinforced
elastomeric matrix can be composed of up to 99% collagen, which can
be cross-linked to provide additional structural integrity. See Datta
1435; see also Final Action 2—16, and Ans. 2—18 (discussing Datta).
FF8. Datta discloses:
The reinforced elastomeric matrix and/or compressed
reinforced elastomeric matrix can be made more functional for
specific uses in various implantable devices by including or
incorporating a reinforcement, e.g., fibers, into the reticulated
cross-linked biodurable elastomeric polycarbonate urea-urethane
matrix. The enhanced functionalities that can be imparted by
using a reinforcement include but are not limited to enhancing
the ability of the device to withstand pull out loads associated
with suturing during surgical procedures, the device’s ability to
be positioned at the repair site by suture anchors during a surgical
procedure, and holding the device at the repair site after the
surgery when the tissue healing takes place. In another
embodiment, the enhanced functionalities provide additional
load bearing capacities to the device during surgery in order to
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facilitate the repair or regeneration of tissues. In another
embodiment, the enhanced functionalities provide additional
load bearing capacities to the device, at least through the initial
days following surgery, in order to facilitate the repair or
regeneration of tissues. In another embodiment, the enhanced
functionalities provide additional load bearing capacities to the
device following surgery in order to facilitate the repair or
regeneration of tissues.
One way of obtaining enhanced functionalities is by
incorporating a reinforcement, e.g., fibers, fiber meshes, wires
and/or sutures, into the elastomeric matrix. Another exemplary
way of obtaining enhanced functionalities is by reinforcing the
matrix with at least one reinforcement. The incorporation of the
reinforcement into the matrix can be achieved by various ways,
including but not limited to stitching, sewing, weaving and
knitting. In one embodiment, the attachment of the
reinforcement to the matrix can be through a sewing stitch.
Datta 299-300; and see id. H 301—307; see also Final Action 2—
16, and Ans. 2—18 (discussing Datta).
FF9. Further to the preceding finding of fact, Datta discloses
that such “reinforcement can be incorporated into the reticulated
elastomeric matrix in different patterns,” such as stitching “along the
border,” and/or “along the perimeter” and/or “in geometrically-shaped
patterns” or lines, so as to improve the implant’s strength as exhibited
by enhanced suture pullout strength, break strength, and ball burst
strength. Datta H 308—322; see also Final Action 2—16, and Ans. 2—
18 (discussing Datta).
FF10. Further to the preceding finding of fact, Datta illustrates
such a stitching reinforcement at Figs. 5a—6d, 9a, 9b, 13, and 14; Fig.
5c is reproduced below:
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The figure above is described by Datta as “illustrating] [an]
exemplary reticulated elastomeric matrix reinforcement grid[].”
“FIG. 5c illustrates a rectangular grid reinforcement element,” where
the implantable device is stitched around its perimeter and in a cross-
hatch, grid pattern across and to the peripheral edges of the device.
Datta 1309; see also Final Action 2—16, and Ans. 2—18 (discussing
Datta).
FF11. Datta discloses “the reinforcement can be made from . . .
copolymers of lactic acid, glycolic acid, lactide, [and] glycolide,” and
“[e]ach fiber can be bi-layered, with an inner core and an outer sheath,
or multi-layered, with inner core, an outer sheath.” Datta 1304—05;
see also Final Action 2—16, and Ans. 2—18 (discussing Datta).
FF12. Datta discloses “[t]he suture pullout strength is from
about 1.1 lbs/ft to about 17 lbs/ft (from about 5 Newtons to about 75
Newtons) in one embodiment or from about 2.3 lbs/ft to about 9.0
lbs/ft (from about 10 Newtons to about 40 Newtons) in another
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embodiment.” Data 1318; see also Final Action 2—16, and Ans. 2—18
(discussing Datta). The Examiner determined Datta taught that suture
pullout strength is a result-effective, optimizable variable that can be
controlled by adjusting the fiber used for reinforcement to enhance the
functionality of the implant device. Final Action 6—7.
FF13. In view of the preceding findings of fact, Datta teaches a
collagen / ECM tissue repair implant having fiber(s) stitched in a
reinforcing pattern to improve the strength, durability, and anchoring
of the implant.
FF14. Badylak discloses “[a] tissue graft construct for use in
repairing diseased or damaged tissues,” which “comprises a matrix
composition,” e.g., “in sheet form,” that “is preferably prepared from
an extracellular matrix composition.” Badylak, abstract, || 6, 18, 41;
see also Final Action 2—3, 8—11, 13—15, and Ans. 2—11, 13—16
(discussing Badylak). Thus, Badylak teaches an extracellular matrix
patch.
FF15. Badylak discloses that such a matrix “provides a unique
cell growth substrate that promotes the attachment and proliferation
of cells in vitro and induces tissue remodeling when the graft
constructs are implanted in vivo,” and “advantageously provides a
physiological environment that supports the proliferation and
differentiation of cells cultured in vitro on the matrix composition.”
Badylak || 4, 31 (emphasis added); see also Final Action 2—3, 8—11,
13—15, and Ans. 2—11, 13—16 (discussing Badylak).
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FF16. Badylak discloses its tissue graft may take the “form [of]
multilayer sheets of submucosa, multiple layers of submucosa can be
overlapped with each other” and “fixed to one another using standard
techniques known to those skilled in the art, including the use of
sutures and biocompatible adhesives such as collagen binder pastes.”
Badylak 1 59; see also Final Action 2—3, 8—11, 13—15, and Ans. 2—11,
13—16 (discussing Badylak).
FF17. In view of the preceding findings of fact, Badylak
teaches a suturable, ECM tissue graft.
FF18. Bilbo discloses a “tissue engineered prostheses made
from processed tissue matrices derived from native tissues that are
biocompatible,” such as collagen derived from “fascia lata,” which
can be in the form laminate sheets and “can serve as a functioning
repair, augmentation, or replacement body part or tissue structure,”
and “when implanted on the damaged or diseased soft tissue,
undergoes controlled biodegradation occurring with adequate living
cell replacement such that the original implanted prosthesis is
remodeled by the patient’s living cells.’ '’ Bilbo, abstract, H 5, 7, 12
(emphasis added); see also Final Action 4—5, 7—8, 10-12, 15—16, and
Ans. 2, 6, 10, 13—17 (discussing Bilbo).
FF19. Bilbo discloses its “processed tissue matrices may be
treated or modified” by “chemical modifications such as binding . . .
extracellular matrix components.” Bilbo 117; see also Final Action
4—5, 7—8, 10-12, 15—16, and Ans. 2, 6, 10, 13—17 (discussing Bilbo).
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FF20. Bilbo discloses the “[intrinsic and functional properties
of the implant, such as the modulus of elasticity, suture retention and
ultimate tensile strength are important parameters which can be
manipulated for specific requirements.” Bilbo 1 5; see also Final
Action 4—5, 7—8, 10-12, 15—16, and Ans. 2, 6, 10, 13—17 (discussing
Bilbo).
FF21. Bilbo discloses making a collagen matrix construct by
“spread[ing an intestinal collagen layer (ICL)] mucosal side down
onto a smooth polycarbonate sheet.” Bilbo 135; see also Final Action
4—5, 7—8, 10-12, 15—16, and Ans. 2, 6, 10, 13—17 (discussing Bilbo).
FF22. Bilbo discloses “[t]he multilayer construct is useful for
treating connective tissue such as in rotator cuff or capsule repair.”
Bilbo 142, 118; see also Final Action 4—5, 7—8, 10-12, 15—16, and
Ans. 2, 6, 10, 13—17 (discussing Bilbo).
FF23. Bilbo discloses its implant “may be populated with cells
to form a cellular tissue construct comprising bonded layers of ICL
and cultured cells,” e.g., progenitor cells, and the “[cjells may also be
genetically engineered to express proteins or different types of
extracellular matrix components which are either ‘normal’ but
expressed at high levels or modified in some way to make a graft
device comprising extracellular matrix.” Bilbo 51, 53, 55; see also
Final Action 4—5, 7—8, 10-12, 15—16, and Ans. 2, 6, 10, 13—17
(discussing Bilbo).
FF24. Bilbo discloses its implant is “‘suturable’ meaning] that
the mechanical properties of the layer include suture retention which
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permits needles and suture materials to pass through the prosthesis
material at the time of suturing of the prosthesis to sections of native
tissue,” where “[intrinsic and functional properties of the implant,
such as the modulus of elasticity, suture retention and ultimate tensile
strength are important parameters which can be manipulated,” and
“the prosthesis resists creep during bioremodeling, and additionally is
pliable and suturable.” Bilbo 5, 23, 38, 40, 63, 64, 118; see also
Final Action 4—5, 7—8, 10-12, 15—16, and Ans. 2, 6, 10, 13—17
(discussing Bilbo).
FF25. Bilbo discloses:
To form prostheses of the invention, the sheets are
fabricated using a method that continues to preserve the
biocompatibility and bioremodelability of the processed matrix
material but also is able to maintain its strength and structural
characteristics for its performance as a replacement tissue. The
processed tissue matrix derived from tissue retains the structural
integrity of the native tissue matrix, that is, the collagenous
matrix structure of the original tissue remains substantially intact
and maintains physical properties so that it will exhibit many
intrinsic and functional properties when implanted. ... In
completed constructs, the bonding region must be able to
withstand suturing and stretching while being handled in the
clinic, during implantation and during the initial healing phase
while functioning as a replacement body part.
Bilbo 123; see also Final Action 4—5, 7—8, 10-12, 15—16, and Ans. 2,
6, 10, 13—17 (discussing Bilbo). Bilbo explains that the suture
retention (measured in Newtons) can be increased by controlling the
cross-linking of collagen. Bilbo 1 87—90, Table 1 (Example 4); see
also Final Action 4—5, 7—8, 10—12, 15—16, and Ans. 2, 6, 10, 13—17
(discussing Bilbo).
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FF26. In view of the preceding findings of fact, Bilbo teaches a
suturable, fascia lata / ECM implant.
FF27. The Oxford Dictionary defines “suture” as follows: “A
stitch or row of stitches holding together the edges of a wound or
surgical incision.” Oxford Dictionary, suture, https://en.oxford-
dictionaries.com/defmition/suture, Sept. 8, 2017 (emphasis added);
see also Advisory Action dated July 29, 2015 and Ans. 8—9, 16
(discussing the meaning of stitching and suturing).
DISCUSSION
Only those arguments made by Appellants in the Briefs have been
considered in this Decision. Arguments not presented in the Briefs are
waived. See 37 C.F.R. § 41.37(c)(l)(iv) (2015). We address both
obviousness rejections together because Appellants present the same
arguments for each.
“[W]hen a patent claims a structure already known in the prior art that
is altered by the mere substitution of one element for another known in the
field, the combination must do more than yield a predictable result.” KSR
Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007), citing United States v.
Adams, 383 U.S. 39, 50-51 (1966). “The combination of familiar elements
according to known methods is likely to be obvious when it does no more
than yield predictable results.” Id. The obviousness analysis “can take
account of the inferences and creative steps that a person of ordinary skill in
the art would employ.” Id. at 418. “A person of ordinary skill is also a
person of ordinary creativity, not an automaton.” Id. at 421.
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“[W]here the general conditions of a claim are disclosed in the prior
art, it is not inventive to discover the optimum or workable ranges by routine
experimentation.” In reAller, 220 F.2d 454, 456 (CCPA 1955). “This rule
is limited to cases in which the optimized variable is a ‘result-effective
variable.’” In re Applied Materials, Inc., 692 F.3d 1289, 1295 (Fed. Cir.
2012) (quoting In re Antonie, 559 F.2d 618, 620 (CCPA 1977)); see also In
re Boesch, 617 F.2d 272, 276 (Fed. Cir. 1980) (“[Discovery of an optimum
value of a result effective variable ... is ordinarily within the skill of the
art.”).
As to motivation to combine separately disclosed subject matter, “the
question is whether there is something in the prior art as a whole to suggest
the desirability, and thus the obviousness, of making the combination, not
whether there is something in the prior art as a whole to suggest that the
combination is the most desirable combination available.” In re Fulton, 391
F.3d 1195, 1200 (Fed. Cir. 2004) (citation omitted).
It is prima facie obvious to combine two [things] each of which
is taught by the prior art to be useful for the same purpose, in
order to form a third [thing] which is to be used for the very same
purpose. . . . [T]he idea of combining them flows logically from
their having been individually taught in the prior art.
In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980).
Reviewing the Examiner’s rationale for the obviousness rejections and
the cited prior art combinations, we find that, under the above-cited
precedent, the Examiner has established that Appellants’ claims (33,38, and
45 are representative) would have been obvious. In agreement with the
Examiner, we find that the prior art combination teaches an implantable
ECM (or fascia lata) patch with a reinforcing stitched fiber (e.g., a fiber-
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stitching-reinforced, tissue graft or patch composed of a reticulated porous
elastomer and up to 99% ECM / collagen / fascia or having an ECM /
collagen / facia coating or sleeve). FF1—FF27. The prior art combination
also teaches that reinforcement stitching can be in the form of cross-hatching
pattern. FF8—FF10. The prior art combination also teaches that reinforcing
fiber can be a bi-layered fiber with a PGA core and a sheath of a mix of PLA
and PGA. FF11. And, as determined by the Examiner, the prior art teaches
or suggests that suture pullout strength is a result-effective, optimizable
variable and, so, optimizing suture pullout strength to be 100N or greater
would be obvious and within the skill in the art. FF12; see also FF20 (Bilbo
identifying that suture retention can be manipulated for specific
requirements).
Further, we find that the skilled artisan would have combined Datta
with Badylak and/or Bilbo because each reference is directed to the same
field of endeavor and use, generally, the same materials to accomplish the
same objectives (that is, an implant incorporating ECM / collagen / fascia to
repair tissue damage and encourage tissue regeneration). Datta teaches that
it would be advantageous to incorporate a layer or coating or pore-filling of
bio-material, such as collagen, with an elastomer matrix to encourage tissue
repair at the implant on a cellular level. Badylak teaches using ECM /
collagen / submucosa in such a suturable implant and Bilbo teaches using
fascia / collagen / ECM components in such a suturable implant, for the very
same purpose. FF3—FF27. Further, the skilled artisan would have
reasonably expected such a combination to succeed because Datta teaches an
elastomeric polymer and collagen are combinable and also reinforceable by
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stitching (FF3—FF13), because, as acknowledged by Appellants, ECM is
collagen, fascia is a type of ECM, and fascia is collagen (FF1).
Appellants have not produced evidence showing, or persuasively
argued, that the Examiner’s determinations are incorrect. We address
Appellants’ arguments below.
Appellants have repeatedly argued that the materials used by Datta
and by Badylak or Bilbo are different and have fundamentally different
properties, but, in conflict with this position, have repeatedly relied on the
common properties of collagen, ECM, and fascia, equating these terms, in
arguing that the properties of elastomers cannot be attributed to such
material. Compare, e.g., App. Br. 15, 16, 18, 19, 23, 28, 30, 31, 34—35, and
Reply Br. 3—5, 7—9, with FF1. Appellants rely on their contention of
material differences, in view of the Badylak Declaration, as the basis for the
argument that the skilled artisan would not combine Datta’s reinforcement
stitching with an ECM (and/or fascia) patch as taught by Badylak (and
Bilbo) and also for the argument that making such a combination would not
reasonably be expected to be successful. This is the over-arching theme of
Appellants’ case; however, Appellants’ arguments wholly ignore that Datta
teaches a patch or implant that is up to 99% collagen / ECM (FF3—FF7,
FF12) and includes reinforcement stitching (FF8—FF12) that improves the
load bearing, positioning, and pullout resistance of such a patch / implant.
Appellants also ignore or dismiss that Badylak teaches an ECM patch that
can be sutured / stitched (FF14—FF17; FF27), that Bilbo teaches an ECM /
fascia patch that is suturable / stitchable and resists tearing (FF18—FF26,
FF23—FF25), and that each of these combined references teaches using
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ECM / collagen / fascia in a patch as support for tissue regeneration (see,
e.g., FF5, FF15, FF18).
Appellants acknowledge several facts:
(1) “Badylak teaches multilayer sheets of the Badylak
submucosa [ECM] can be formed by overlapping a single
submucosa [ECM] sheet and fixing the sheets to one another
using sutures ... to provide a means for holding the sheets
together” (App. Br. 15, 21);
(2) Badylak and Datta can be combined and “can be used for
tissue repair” (id. at 17);
(3) “Datta and Badylak [are] in the same field of endeavor” (id.
at 19);
(4) “[i]t is true that ECM grafts are commonly sutured during
surgery” (id. at 20);
(5) “stitching can be done to enhance the strength of a reticulated
elastomer (as taught by Datta [as being 99% collagen])” (id. at
22—24 (acknowledging Datta’s disclosed “void volume of 10-
99%”)); and
(6) “fascia ... is one type of ECM . . . [t]hus, discussion of the
ECM patch of Badylak in the Declaration is equally applicable
to the fascia patch of Bilbo.” (id. at 36—37).
We agree with the Examiner that it would be obvious to combine the
matrix of Datta with the ECM material of Badylak or the collagen / fascia
material of Bilbo, and also find that Datta itself teaches and suggests a patch
composed of up to 99% collagen, which Appellants equate to ECM and
fascia, which suggests that if a collagen-based implant can be reinforced by
stitching, as taught by Datta, an ECM-based and/or fascia-based patch can
similarly be reinforced by stitching. In view of the findings of fact and
Appellants-acknowledged facts set forth above, it is apparent that the cited
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Appeal 2016-006258
Application 14/097,328
prior art combination would reasonably have been made by the skilled
artisan and reasonably would have been expected to be made successfully.
Appellants’ arguments that differences between the materials of Datta
and the other references would not allow one to transfer understanding of
reinforcing stitching from one reference to the other are not persuasive. The
stitching disclosed to be reinforcing in Datta would likewise be reinforcing if
one of skill were to use Badylak’s ECM or Bilbo’s fascia lata as Datta’s bio-
material-coating or pore-filling, as the references suggest. Datta itself
discloses that its implant, taught as reinforced by cross-hatched stitching, is
up to 99% collagen (once again, Appellants identify that ECM is collagen at,
inter alia, Table 1 of their brief, and that fascia is ECM at page 35 of their
brief — see FF1). Thus, Appellants’ contentions that Datta does not teach
and suggest that such stitching would improve the fixation retention of an
ECM or fascia patch is not persuasive.
For the above reasons, we affirm the rejection over Datta and Badylak
and the rejection over Datta and Bilbo.
SUMMARY
The rejections of the claims as obvious are each affirmed.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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